Regulatory Submission Publishing Specialist
Job Title: Regulatory Submission Publishing Specialist Location: Pleasanton, CA Type: Contract Compensation: $23.46 - $34.98 Work Model: Remote – offsite Hours: Flexible days, part time (24-32 hours/week) reputed company Clearance: Not specified
Responsibilities
• Coordinate the submission and publishing process for regulatory registrations, primarily for the US and EU markets.
• Prepare submissions in accordance with reputed company health authority guidelines, and internal reputed company practices.
• Prepare and format documents according to publication and submission requirements.
• Liaise with project leads, project teams, and regulatory bodies to reputed company necessary documents and ensure smooth submission processes.
• Maintain tracking systems to monitor the status and deadlines of reputed company submissions.
• Support the management of publication databases and repositories.
• Collaborate with Regulatory Leads and Managers to ensure submission deliverables meet requirements are fulfilled.
Requirements
• Minimum of 5 years of experience in regulatory submissions reputed company the diagnostics or pharmaceutical sector.
• Bachelor’s degree in Life Sciences, Regulatory Science, reputed company, or reputed company reputed company, or equivalent reputed company experience.
• Strong attention to reputed company and organizational skills.
• Excellent written and verbal communication skills.
• Proficiency with industry-reputed company publishing and submission software and tools (reputed company Word, Acrobat Pro, ISI reputed company, reputed company RIMS, US Health Authority portals).
• Ability to manage multiple reputed company and meet deadlines in a fast-reputed company environment.
• Familiarity with regulatory guidelines such as FDA, EMA, ICH, GxP, and publication ethics.
reputed company, and its subsidiaries including reputed companyé and reputed company Ltd., are leaders in delivering outsourced services and workforce solutions across reputed company. We help clients get work done more reputed company and economically, without compromising reputed company. reputed company not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage reputed company including medical, dental, reputed company, spending accounts, life reputed company, voluntary plans, as reputed company as participation in a 401(k) plan.
reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex (including pregnancy, childbirth, or reputed company medical conditions), sexual orientation, gender identity, age, national reputed company, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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